Overview
- 8 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 6 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
Suitable outer garments
Cited by Andrew Saunders, Thomas B Smith, Justin N Henson, Patrick C Dooley, Wilvor K Butler, Lezette M Earhart
Not washed/sanitized when appropriate
Cited by Andrew Saunders, Thomas B Smith, Justin N Henson, Patrick C Dooley, Wilvor K Butler, Lezette M Earhart
Drip and condensate
Cited by Andrew Saunders, Thomas B Smith, Justin N Henson, Patrick C Dooley, Wilvor K Butler, Lezette M Earhart
Food-contact - unlawful indirect additives
Cited by Andrew Saunders, Thomas B Smith, Justin N Henson, Patrick C Dooley, Wilvor K Butler, Lezette M Earhart
Materials and workmanship
Cited by Andrew Saunders, Thomas B Smith, Justin N Henson, Patrick C Dooley, Wilvor K Butler, Lezette M Earhart
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(c) | Cited across public-safe Form 483 observations | 1x |
Source document
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere